Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 56369 

■ 4. Subpart G of part 82 is amended by 

adding Appendix P to read as follows: 

Appendix P to subpart G of part 82- 

Substitutes listed in the September 27, 

2006 Final Rule, effective November 27, 

2006 

FIRE SUPPRESSION AND EXPLOSION PROTECTION SECTOR—TOTAL FLOODING AGENTS—ACCEPTABLE SUBJECT TO

NARROWED USE LIMITS

End-use Substitute Decision Conditions Further information 

Total flooding ......... Gelled Halocarbon/Dry Chemical Suspension with any agent other than 

ammonium polyphosphate or sodium bicarbonate additive 

(Envirogel with sodium bicarbonate 

additive).

Acceptable subject 

to narrowed use 

limits.

For use only in 

normally unoccupied areas.

Use of this agent should be in accordance with the safety guidelines in 

the latest edition of the NFPA 2001 

Standard for Clean Agent Fire Extinguishing Systems, for whichever 

hydrofluorocarbon gas is employed. 

Envirogel is listed as a streaming substitute under the generic name 

Gelled Halocarbon/Dry Chemical 

Suspension. Envirogel was also 

previously listed as a total flooding 

substitute under the same generic 

name. 

EPA has found Envirogel with the ammonium polyphosphate additive and 

Envirogel with the sodium bicarbonate additive to be acceptable as 

total flooding agents in both occupied and unoccupied areas. 

See additional comments 1, 2, 3, 4, 5 

Additional comments: 

1—Should conform to relevant OSHA requirements, including 29 CFR 1910, subpart L, Sections 1910.160 and 1910.162. 

2—Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the area. 

3—Discharge testing should be strictly limited to that which is essential to meet safety or performance requirements. 

4—The agent should be recovered from the fire protection system in conjunction with testing or servicing, and recycled for later use or destroyed. 

5—EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other occupational safety and health standard with respect to halon 

substitutes. 

[FR Doc. E6–15831 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0645; FRL–8092–6] 

Pendimethalin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenyzl alcohol in or 

on alfalfa, forage; alfalfa, hay; alfalfa, 

seed; apple, wet pomace; fruit, pome, 

group 11; fruit, stone, group 12; 

juneberry; leek; onion, green; onion, 

welsh; pomegranate; shallot; strawberry; 

vegetable, fruiting, group 8; wheat, 

grain; wheat, forage; wheat, hay; and 

wheat, straw. BASF Corporation and 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006 and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0645. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305 5697; e-mail address: 

tompkins.jim@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 


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• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0645 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 27, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0645 by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of June 14, 

2006 (71 FR 34341–34342) (FRL–8072–

1), EPA issued a notice pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions PP 0E6175 

(vegetable, fruiting, group 8), PP 2E6450 

(fruit, pome, group 11; apple, wet 

pomace; and juneberry), PP 2E6464 

(fruit, stone, group 12), PP 2E6449 

(pomegranates), by Interregional 

Research Project Number 4 (IR–4), 681 

U.S. Highway #1 South, New 

Brunswick, NJ 08902–390. 

In the Federal Register of June 14, 

2006 (71 FR 34344–34345) (FRL–8072–

7), EPA issued a notice pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions PP 5E6927 (onion, 

green; onion, welsh; leek; and shallot), 

PP 5E6928 (strawberry), by Interregional 

Research Project Number 4 (IR–4), 681 

U.S. Highway #1 South, New 

Brunswick, NJ 08902–390. 

In the Federal Register of August 18, 

2006 (71 FR 47810–47811 (FRL–8084–

71), EPA issued a notice pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions PP 4F6870 (wheat, 

grain; wheat, forage; wheat, hay; and 

wheat, straw), and PP 5F6961 (alfalfa, 

forage; alfalfa, hay; and alfalfa, seed) by 

BASF Corporation Agricultural 

Products, P.O. Box 13528, Research 

Triangle Park, NC 27709–3528. 

These petitions requested that 40 CFR 

180.361 be amended by establishing a 

tolerance for combined residues of the 

herbicide pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, and its metabolite 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenyzl alcohol in or on 

vegetables, fruiting, group 8 at 0.10 ppm 

(PP 0E6175), fruit, pome, group 11 at 

0.10 ppm; apple, wet pomace at 0.20 

ppm; and juneberry at 0.10 ppm (PP 

2E6450), fruit, stone, group 12 at 0.10 

ppm (PP 2E6464), pomergranate at 0.10 

ppm (PP 2E6449), onion, green at 0.20 

ppm; onion, welsh at 0.20 ppm, leek at 

0.20 ppm; and shallot at 0.2 ppm (PP 

5E6927), strawberry at 0.10 ppm (PP 

5E6928), wheat, grain at 0.10 ppm; 

wheat, forge at 3.0 ppm; wheat, hay at 

0.60 ppm; and wheat, straw at 0.30 

ppm; (PP 4F6870), alfalfa, forage at 3.0 

ppm; alfalfa, hay at 4.0 ppm; and alfalfa, 

seed at 0.10 ppm (PP 5F6961). These 

notices included a summary of the 

petition prepared by IR-4 and BASF 

Corporation, the registrant. One 

comment was received in response to 

the notices of filing. EPA’s response to 

this comment is discussed in Unit IV.C. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 


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available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, and its metabolite 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenyzl alcohol in or on 

vegetables, fruiting, group 8 at 0.10 

ppm; fruit, pome, group 11 at 0.10 ppm; 

apple, wet pomace at 0.20 ppm; 

juneberry at 0.10 ppm; fruit, stone, 

group 12 at 0.10 ppm; pomergranate at 

0.10 ppm; onion, green at 0.20 ppm; 

onion, welsh at 0.20 ppm; leek at 0.20 

ppm, shallot at 0.2 ppm; strawberry at 

0.10 ppm; wheat, grain at 0.10 ppm; 

wheat, forge at 3.0 ppm; wheat, hay at 

0.60 ppm, wheat, straw at 0.30 ppm; 

alfalfa, forage at 3.0 ppm; alfalfa, hay at 

4.0 ppm; and alfalfa, seed at 0.10 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing the 

tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

pendimethalin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:/ 

www.regulations.gov/fdmspublic/ 

component/main, see Docket OPP–

2005–0056–0002. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

fedrgstr/EPA-PEST/1997/November/ 

Day-26/p30948.htm. 

A summary of the toxicological 

endpoints for pendimethalin used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of April 12, 2006, 

70 FR 18628–18635 (FRL–7770–4) 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.361) for the 

combined residues of pendimethalin, N- 

(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, and its metabolite 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenyzl alcohol, in or on a variety 

of raw agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

pendimethalin in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a one-day or 

single exposure. No such effects were 

identified in the toxicological studies 

for pendimethalin; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. 

Tolerance-level residues were assumed 

for all food commodities with current 

and proposed pendimethalin tolerances, 

and it was assumed that all of the crops 

included in the analysis were treated 

(i.e., 100% crop treated). These 

assumptions result in highly 

conservative estimates of dietary 

exposure and risk. 

iii. Cancer. Pendimethalin is 

classified ‘‘Group C,’’ possible human 

carcinogen, chemical based on a 

statistically significant increased trend 

and pair-wise comparison between the 

high dose group and controls for thyroid 

follicular cell adenomas in male and 

female rats. The Agency used a nonlinear approach (i.e., reference dose 

(RfD) approach) since mode of action 

studies are available that demonstrate 

that the thyroid tumors are due to a 

thyroid-pituitary imbalance, and also 

since pendimethalin was shown to be 

non-mutagenic in mammalian somatic 

cells and germ. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

pendimethalin in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

pendimethalin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model-Exposure Analysis Modeling 

System (PRZM-EXAMS) and screening 

concentration in ground water (SCIGROW) models, the estimated 

environmental concentrations (EECs) of 

pendimethalin for acute exposures are 

estimated to be 39 parts per billion 

(ppb) for surface water and 0.024 ppb 

for ground water. The EECs for chronic 

exposures are estimated to be 4.8 ppb 

for surface water and 0.024 ppb for 

ground water. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model (DEEM-FCIDTM, 

Version 2.03). An acute dietary risk 

assessment for the peak water 

concentration value was not done 

because no such effects were identified 

in the toxicological studies for 

pendimethalin. For chronic dietary risk 

assessment, an estimated drinking water 

concentration (EDWC) of 0.039 ppm, the 

1 in 10 year annual peak concentration 

in surface water as calculated by PRZMEXAMS modeling, resulting from a 

single application of pendimethalin to 

apples at a rate of 4.0 lb of active 

ingredient/acre, was entered into DEEM. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 


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flea and tick control on pets). 

Pendimethalin is currently registered for 

use on the following residential nondietary sites: Landscapes, grounds 

plantings, ornamental crops, turf grass, 

and lawns. The risk assessment for 

residential non-dietary sites is discussed 

in Unit III.C.3. of the final rule 

published in the Federal Register of 

April 12, 2006, FR Page 18628–18635 

(FRL–7770–4) 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

pendimethalin and any other substances 

and pendimethalin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that pendimethalin has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a margin of exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional uncertainty factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The data base for pendimethalin does 

not indicate a potential for increased 

toxicological sensitivity from either 

prenatal or postnatal exposures. No 

developmental toxicity was observed in 

either the rat or rabbit developmental 

toxicity studies, nor was there evidence 

in the two-generation reproduction 

study of developmental or reproductive 

toxicity at dose levels below those in 

which parental toxicity was observed. 

There was no neurotoxicity observed in 

the submitted toxicity studies. 

Therefore, a developmental 

neurotoxicity (DNT) study is not 

required. 

Available data show the thyroid is a 

target organ for pendimethalin. The 

endpoints and doses selected for risk 

assessment were based on the most 

sensitive effect, thyroid toxicity, which 

was well-characterized in both chronic 

and subchronic toxicity studies on the 

basis of clear NOAELs and LOAELs. In 

addition, the exposure data used to 

evaluate risks for the general U.S. 

population and infants and children are 

conservative, and therefore the 

calculated risks are considered to be 

protective. 

3. Conclusion. There was no evidence 

of qualitative or quantitative 

susceptibility in the submitted data. 

Additionally, exposure estimates are 

based on very conservative data and 

assumptions that will overstate 

exposure to pendimethalin. There is, 

however, a concern that perturbation of 

thyroid homeostatis may lead to 

hypothyroidism, and possibly result in 

adverse effects on the developing 

nervous system. Since thyroid toxicity 

parameters were not measured in the 

developmental toxicity studies, the 

Agency has requested a developmental 

thyroid assay be conducted to evaluate 

the impact of pendimethalin on thyroid 

hormones, structure, and/or thyroid 

hormone homeostasis during 

development. The Agency has retained 

the additional 10X FQPA safety factor in 

the form of a database uncertainty factor 

(UFDB) for the lack of the study, to be 

applied in determining pendimethalin 

risks. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. No toxic effects 

attributed to a single dose were 

identified for pendimethalin. Therefore 

an acute risk is not anticipated for this 

chemical. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to pendimethalin from 

food and drinking water will utilize 

11% of the chronic population adjusted 

dose (cPAD) for the U.S. population, 

19% of the cPAD for infants, and 26% 

of the cPAD for Children 1 to 2 years of 

age. Based on the use pattern, chronic 

residential exposure to residues of 

pendimethalin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pendimethalin is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for pendimethalin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, drinking water and residential 

exposures aggregated result in aggregate 

MOEs of 580 for adult males, 520 for 

females 13 years or older, and 310 for 

children 1 to 2 years old. These 

aggregate MOEs do not exceed the 

Agency’s level of concern (MOE 300) for 

aggregate exposure to food, drinking 

water and residential uses. See 71 FR 

18628–18630, April 12, 2006. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Based on the currently 

registered and requested uses, there are 

no scenarios that are likely to result in 

intermediate-term exposure (30 to 180 

days, continuously). Therefore an 

intermediate-term risk is not anticipated 

for pendimethalin. 

5. Aggregate cancer risk for U.S. 

population. The Agency determined 

that the 0.10 mg/kg/day RfD for chronic 

risks, is protective of both the chronic, 

non-carcinogenic effects as well as the 

carcinogenic effect seen in the rat. 

Accordingly, based on the risk estimates 

for chronic risk above, EPA concludes 

that aggregate chronic exposure to 

pendimethalin is not expected to pose a 

cancer risk of concern. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

pendimethalin and its metabolite 

residues. 


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IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methods are available for 

data collection and tolerance 

enforcement for existing and proposed 

uses of pendimethalin. Methods I 

through IV in PAM Vol. II are gas 

chromatography/electron capture (GC/ 

ECD) methods. Methods used for data 

collection are essentially the same as the 

PAM Vol. II methods, and have been 

adequately validated. 

The FDA PESTDATA database (PAM 

Volume I, Appendix I) indicates that 

pendimethalin is completely recovered 

(>80%) by Multiresidue Methods 

Section 302 (Luke method; Protocol D) 

and 303 (Mills, Onley, Gaither method; 

Protocol E, nonfatty), and partially 

recovered (50–80%) by Multiresidue 

Method Section 304 (Mills fatty food 

method; Protocol E, fatty). The method 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no established or proposed 

Codex maximum residue limits (MRLs) 

for pendimethalin residues. Therefore, 

there are no questions of compatibility 

with respect to Codex MRLs and U.S. 

tolerances. 

C. Response to Comments 

One comment was received in 

response to the notices of filing for this 

action. The comment contained no 

scientific data or other substantive 

evidence to rebut the Agency’s 

conclusion that there is a reasonable 

certaintythat no harm will result from 

aggregate exposure to pendimethalin 

from the establishment of these 

tolerances. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenyzl alcohol in or 

on alfalfa, forage at 3.0 ppm; alfalfa, hay 

at 4.0 ppm; and alfalfa, seed at 0.10 

ppm; fruit, pome, group 11 at 0.10 ppm; 

apple, wet pomace at 0.20 ppm and 

juneberry at 0.10 ppm; fruit, stone, 

group 12 at 0.10 ppm; pomergranate at 

0.10 ppm; onion, green at 0.20 ppm; 

onion, welsh at 0.20 ppm; leek at 0.20 

ppm; and shallot at 0.2 ppm; strawberry 

at 0.10 ppm; wheat, grain at 0.10 ppm; 

wheat, forge at 3.0 ppm; wheat, hay at 

0.60 ppm; wheat, straw at 0.30 ppm; 

and vegetables, fruiting, group 8 at 0.10 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994), or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 


sroberts on PROD1PC70 with RULES
56374 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 19, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.361 is amended by 

adding entries to the table in paragraph 

(a) to read as follows: 

§ 180.361 Pendimethalin, Tolerances for 

Residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

Alfalfa, Forage ..................................... 3.0 

Alfalfa, Hay .......................................... 4.0 

Alfalfa, Seed ........................................ 0.10 

Apple, wet pomace .............................. 0.20 

* * * * * 

Fruit, pome, group 11 .......................... 0.10 

Fruit, stone, group 12 .......................... 0.10 

* * * * * 

Juneberry ............................................. 0.10 

Leek ..................................................... 0.20 

* * * * * 

Onion, green ........................................ 0.20 

Onion, welsh ........................................ 0.20 

* * * * * 

Pomegranate ....................................... 0.10 

* * * * * 

Shallot .................................................. 0.2 

* * * * * 

Strawberry ........................................... 0.10 

* * * * * 

Vegetable, fruiting, group 8 ................. 0.10 

Wheat, grain ........................................ 0.10 

Wheat, forage ...................................... 3.0 

Wheat, hay .......................................... 0.60 

Wheat, straw ....................................... 0.30 

[FR Doc. 06–8254 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0204; FRL–8094–5] 

Quizalofop ethyl; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

quizalofop ethyl in or on the raw 

agricultural commodities barley, grain; 

barley, hay; barley, straw; flax, seed; 

milk, fat; sunflower, seed; wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw. Nissan Chemical Industries, Ltd 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0204. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

James A. Tompkins, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: 703–305–5697; e-mail address: 

Tompkins.jim@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 


sroberts on PROD1PC70 with RULES